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Biologikaregister JuMBO

Langzeitsicherheit von Biologikatherapie bei juveniler idiopathischer Arthritis

Biologics register JuMBO

Long-term safety of biologic therapy of juvenile idiopathic arthritis

  • Leitthema
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Zeitschrift für Rheumatologie Aims and scope Submit manuscript

Zusammenfassung

Die Therapie der juvenilen idiopathischen Arthritis (JIA) hat sich in den letzten Jahren gravierend geändert. Mittlerweile erhält hierzulande jedes dritte Kind mit polyartikulärer JIA ein Biologikum. Die Kenntnisse zur Langzeitsicherheit der Biologika sind noch begrenzt. Informationen hierzu werden mit dem JIA-Biologikaregister BiKeR und dessen Follow-up-Register JuMBO (Juvenile Arthritis Methotrexat/Biologics long-term observation) erhoben. Letzteres umfasst derzeit über 700 junge Erwachsene. Die meisten wurden mit Etanercept behandelt und über mehr als 5 Jahre beobachtet. Erste Rückschlüsse auf die Langzeitsicherheit einer Etanercept-Therapie bei der JIA können deshalb gezogen werden. Über einen Beobachtungszeitraum von 1800 Expositionsjahren wurden Malignome, schwere Infektionen und inzidente immunvermittelte Erkrankungen mit Raten von 0,1, 1,1 bzw. 0,9/100 Patientenjahre erfasst. Neue Sicherheitsrisiken bei längerer Etanercept-Exposition wurden nicht aufgedeckt. Zusätzlich werden mit JuMBO Informationen zum Langzeitoutcome der Patienten gewonnen. Diese belegen eine Verbesserung der Langzeitprognose der JIA vor allem im funktionellen Bereich. Daten des BiKeR/JuMBO-Registers tragen zur Risiko-Nutzen-Bewertung der bei der JIA eingesetzten Biologika bei.

Abstract

In recent years the treatment of juvenile idiopathic arthritis (JIA) has changed dramatically. Nowadays one out of three children with polyarticular JIA is treated with a biologic drug; however, knowledge about the long-term safety of biologics is still limited. Information on drug safety is collected in the JIA biologic register (BiKeR) and the follow-up register juvenile arthritis methotrexate/biologics long-term observation (JuMBO). The latter currently includes information on more than 700 young adults most of whom were treated with etanercept and prospectively followed for more than 5 years. Preliminary data on the long-term safety of etanercept for JIA are therefore available. Over an observation period of 1,800 etanercept exposure-years, events of particular interest, such as malignancies, serious infections and new onset immune-mediated diseases have been recorded which occurred at rates of 0.1, 1.1 and 0.9/100 patient-years, respectively. Overall, new safety risks were not detected during long-term etanercept exposure. Moreover, JuMBO has also provided information on the long-term outcome of JIA and initial evidence suggests that JIA outcome, especially in functional aspects has improved in the biologic era. Data from BiKeR and JuMBO contribute to the risk-benefit assessment of biologic drugs which have been implemented in the routine treatment of JIA.

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Danksagung

Wir bedanken uns bei den Patienten für die regelmäßige Beantwortung unserer Fragebögen. Auch danken wir allen pädiatrischen bzw. internistischen Einrichtungen insbesondere: E. Seipelt, Berlin; J.P. Haas, Garmisch-Partenkirchen; G. Keysser, Halle; C. Baumann, Plauen; P. Aries, Hamburg; I. Foeldvari, Hamburg; G. Ganser, Sendenhorst; M. Hammer, Sendenhorst; J. Hennes, Tübingen; R.M. Küster, Wedel. Ganz herzlich möchten wir Karin Weber für das sorgfältige Monitoring im Rahmen des Projektes danken. Das JuMBO-Register wird durch einen „unconditional grant“ der Firma Pfizer Pharma GmbH unterstützt.

Interessenkonflikt

Die korrespondierende Autorin weist für sich und ihre Koautoren auf folgende Beziehungen hin: Kirsten Minden erhält Forschungsgelder, ist als Referentin oder Beraterin für die Firmen Abbott, Chugai Pharmaceutical, Novartis, Medac, Pfizer und Roche tätig.

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Authors and Affiliations

  1. Deutsches Rheuma-Forschungszentrum Berlin, ein Institut der Leibnizgemeinschaft, Programmbereich Epidemiologie, Charitéplatz 1, 10117, Berlin, Deutschland

    K. Minden, J. Klotsche, M. Niewerth MPH & A. Zink

  2. Universitätskinderklinik Charité, Campus Virchow, Berlin, Deutschland

    K. Minden

  3. Asklepios Kinderklinik St. Augustin GmbH, Sankt Augustin, Deutschland

    G. Horneff

Authors
  1. K. Minden
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  2. J. Klotsche
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  3. M. Niewerth MPH
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  4. G. Horneff
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  5. A. Zink
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Correspondence to K. Minden.

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Minden, K., Klotsche, J., Niewerth, M. et al. Biologikaregister JuMBO. Z. Rheumatol. 72, 339–346 (2013). https://doi.org/10.1007/s00393-012-1063-z

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  • DOI: https://doi.org/10.1007/s00393-012-1063-z

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